Brain Injuries, TraumaticPhase 3NCT00316004
Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)
A Phase 3 study testing 7.5% Hypertonic Saline in 6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS) and 0.9% Normal Saline (NS) in people with Brain Injuries, Traumatic, run by University of Washington at 12 sites in 2 countries.
Trial summary
The purpose of this study is to determine if hypertonic saline with and without dextran can improve neurologic outcomes in victims of severe traumatic brain injury (TBI). Injury and lost blood from trauma can cause your body to go into shock (low blood pressure related to blood loss). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- 7.5% Hypertonic Saline in 6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS) and 0.9% Normal Saline (NS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,331 participants
- Where
- 12 sitesin 2 countries
- Study dates
- May 2006to Jan 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Blunt trauma
- Pre-hospital Glasgow Coma Scale equal to or less than 8(GCS≤8)*
- Age 15 years or older or 50 kg or more
- Patients who met the inclusion criteria above and did not meet the exclusion criteria below but who had systolic blood pressure (SBP) ≤70 or SBP>70 and SBP≤90 and heart rate (HR)≥108 were included in the Hypertonic Resuscitation following Traumatic Injury study that focused on shock patients who may or may not have a traumatic brain injury (TBI). In other words, patients with both TBI and shock would not be included in this study of TBI patients without shock at the time of enrollment.
Who cannot join
- Known or suspected pregnancy
- Age younger than 15 years or less than 50 kg if age unknown
- Ongoing pre-hospital cardiopulmonary resuscitation (CPR)
- Administration of more than 2L crystalloid or any colloid or blood products
- Severe hypothermia (T less than 28C)
- Drowning or asphyxia due to hanging
Show all 11Show fewer
- Burns TBSA more than 20%
- Isolated penetrating injury to the head
- Inability to obtain pre-hospital intravenous access
- Time of call received at dispatch to study intervention more than four hours
- Known prisoners
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States10 sites
Alabama Resuscitation Center, University of Alabama
Birmingham, Alabama, 35249
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Iowa Resuscitation Network, University of Iowa Carver College of Medicine
Iowa City, Iowa, 52242
The Regional Medical Center at Memphis
Memphis, Tennessee, 38103
Milwaukee Resuscitation Network, Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Orange County/UC Irvine
Orange, California, 92868
The Pittsburgh Resuscitation Network, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
Portland, Oregon, 97239
UCSD-San Diego Resuscitation Research Center
San Diego, California, 92103
Seattle-King County Center for Resuscitation Research, University of Washington
Seattle, Washington, 98195
Canada2 sites
University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research Institute
Ottawa, Ontario, K1Y4E9
Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto
Toronto, Ontario, M5B1W8
About this study
Official title: Phase 3 Study of Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)
The purpose of this study is to determine if hypertonic saline with and without dextran can improve neurologic outcomes in victims of severe traumatic brain injury (TBI).
Injury and lost blood from trauma can cause your body to go into shock (low blood pressure related to blood loss). This decreased blood flow can lead to organ damage. In order to restore the blood pressure and blood flow, the medics give fluids into the patients' veins as soon as possible. This is called "resuscitation". The fluid most commonly used is "isotonic" or one that is the same salt concentration as the blood. The investigators are trying to determine if infusing a "hypertonic" fluid or one more concentrated than the blood can increase the blood pressure and restore blood flow more efficiently. The hypertonic fluids they are using are called hypertonic saline with dextran (HSD) and hypertonic saline (no dextran). Hypertonic saline is a salt solution that is slightly more concentrated than blood. Dextran is a sugar solution.
Read the detailed description
To determine if prehospital administration of 7.5% Hypertonic Saline in 6% Dextran-70 (HSD) OR 7.5% Hypertonic Saline (HS) compared to current standard therapy with NS as an initial resuscitation fluid affects neurological outcome following severe traumatic brain injury.
Trauma is the leading cause of death among North Americans between the ages of 1 and 44 years. The majority of these deaths result from hypovolemic shock or severe brain injury. Patients in hypovolemic shock develop a state of systemic tissue ischemia then a subsequent reperfusion injury at the time of fluid resuscitation. Conventional resuscitation involves the IV administration of a large volume of isotonic or slightly hypotonic (lactated ringers, LR) solutions beginning in the pre-hospital setting. Although not conclusive, prior studies have suggested that alternative resuscitation with hypertonic saline (7.5%) solutions may reduce morbidity or mortality in these patients. Furthermore, hypertonic fluids may have specific advantages in the brain-injured patient, as they may aid in the rapid restoration of cerebral perfusion and prevent extravascular fluid sequestration, thereby limiting secondary brain injury. In addition, recent studies have demonstrated that hypertonicity significantly alters the activation of inflammatory cells, an effect that may reduce subsequent organ injury from ischemia-reperfusion and decrease nosocomial infection.
This study is a randomized, double-blind, three-arm placebo controlled trial designed to evaluate the clinical outcome of trauma patients with severe TBI as manifested by a pre-hospital GCS of 8 or less. Patients will be randomized to a single 250cc IV dose of 7.5% saline in 6% Dextran-70 (HSD), 7.5% saline (HS) or normal saline as the initial fluid for pre-hospital resuscitation. No additional interventions will occur once the patient is admitted to the hospital. In hospital data collection will last up to 28 days. Patients will have neurologic outcome measurements at discharge, 1 month post discharge, and 6 months post injury. Enrollment will be restricted to age ≥ 15 years or ≥ 50 kg if age is unknown.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- 7.5% Hypertonic Saline in 6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS), 0.9% Normal Saline (NS)
- Keywords
- Traumatic, Brain injury
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7.5% Hypertonic Saline in 6% Dextran-70 (HSD)Drug
Also called RescueFlo
250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
7.5% Hypertonic Saline (HS)Drug
250 ml intravenous bolus administration of 7.5% hypertonic saline administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
0.9% Normal Saline (NS)Drug
250 ml intravenous bolus administration of 0.9% saline administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| 7.5% hypertonic saline/6% dextran (HSD) | Experimental | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 Receives: Drug: 7.5% Hypertonic Saline in 6% Dextran-70 (HSD) |
| 7.5% hypertonic saline (HS) | Experimental | 250 ml intravenous bolus administration of 7.5% hypertonic saline Receives: Drug: 7.5% Hypertonic Saline (HS) |
| 0.9% normal saline (NS) | Placebo comparator | 250 ml intravenous bolus administration of 0.9% saline Receives: Drug: 0.9% Normal Saline (NS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Completer Analysis
Glasgow outcome score extended (GOSE) contains eight categories: 1. Dead, 2. Vegetative State (VS), 3. Lower Severe Disability (Lower SD), 4. Upper Severe Disability (Upper SD), 5. Lower Moderate Disability (Lower MD), 6. Upper Moderate Disability (Upper MD), 7. Lower Good Recovery (Lower GR) and 8. Upper Good Recovery (Upper GR). A measured neurological outcome of GOSE≤4 is a poor outcome of severe disability, vegetative state, or death. Completer analysis includes only those patients with GOSE completed at 6 months after injury.
Measured: 6 months after injury
Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis
Glasgow outcome score extended (GOSE) contains 8 categories: 1. Dead, 2. Vegetative State, 3. Lower Severe Disability, 4. Upper Severe Disability, 5. Lower Moderate Disability, 6. Upper Moderate Disability, 7. Lower Good Recovery and 8. Upper Good Recovery. To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.
Measured: 6 months after injury
Secondary outcomes (14)
Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 4 (Head AIS≥4) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis
The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥4, which is a diagnostic indicator of severe to lethal head injury. Of this subset of participants with AIS≥4, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE.
Measured: 6 months after injury
Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 2 (Head AIS≥2) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis
The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥2, which is a diagnostic indicator of moderate to lethal head injury. Of this subset of participants with AIS≥2, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE.
Measured: 6 months after injury
Disability Rating Score (DRS) Categories of Disability
The DRS is an additional measure of neurological outcome that categorizes the patient's level of disability on a scale of 0 to 29, with 0 indicating no disability to 29 indicating extreme vegetative state. To adjust for 15% of subjects with absent 6-month DRS data, an analysis using 20 hot deck imputations for the 6-month DRS was done using data from patients who were discharged alive based on 1-month post discharge DRS data or discharge DRS (if 1-month post discharge data were not available), length of hospital stay, and treatment group.
Measured: 6 months after injury
28 Day Survival
The patient who is admitted to the hospital after injury and is alive on the 28th day after injury. For 28-day survival, patients with missing 28-day vital status who were known to be discharged alive prior to 28 days were assumed to be alive at day 28.
Measured: 28 days after injury
Survival at Hospital Discharge up to 6 Months From Date of Injury
The patient who is admitted to the hospital alive after injury and is alive when discharged from the hospital up to 6 months from the date of injury.
Measured: Date of hospital discharge up to 6 months from date of injury
Acute Respiratory Distress Syndrome (ARDS)-Free Survival to Day 28
The patient is alive and free of ARDS from the date of injury through to the 28th day following injury. The diagnosis of ARDS is based on standard criteria: a) hypoxia with a ratio of arterial oxygen pressure to percent oxygen delivered of less than 200; b) bilateral infiltrates on chest X-ray; and c) clinical evidence of increased left atrial pressure or pulmonary artery wedge pressure of greater than 18 mmHg.
Measured: From day of injury to 28 days after injury
Worst Multiple Organ Dysfunction Score (MODS) Through Day 28
Multiple Organ Dysfunction Score is described as: Six organ systems were chosen: 1) respiratory; 2) renal; 3) hepatic; 4) cardiovascular; 5) hematologic; and 6) neurologica. A score of 0-4 was allotted for each organ according to function (0 being normal function through 4 for most severe dysfunction) with a maximum score of 24. The worst score based on available data (missing values were assumed normal) was taken for calculation of the aggregate score. Deaths are assigned the worst score (24).
Measured: From day of injury to 28 days after injury
Ventilator-free Days Through Day 28
The number of days beginning with the day of 911 call counted as "Day 0" through day 28 that the patient did not require mechanical ventilation. Deaths are assigned the worst score (0).
Measured: From day of injury to 28 days after injury
Days Alive Out of the Intensive Care Unit (ICU) Through Day 28
The number of days the patient is alive and not being cared for in the intensive care unit
Measured: From day of injury to 28 days after injury
Days Alive Out of the Hospital Through Day 28
The number of days the patient is alive and no longer an inpatient in the hospital through day 28
Measured: From day of injury to 28 days after injury
Presence of Nosocomial Infections
Includes one or more nosocomial infections diagnosed during the hospital stay but not present on admission to the hospital from the following list: pneumonia, bloodstream infection, urinary tract infection, and/or wound infection
Measured: From day of injury to 28 days after injury
Total Fluids in First 24 Hours
The average (mean) total amount of intravenous (IV) fluids given in the pre-hospital setting and the hospital setting in the first 24 hours following the time of the 911 call
Measured: First 24 hours from the time dispatch received 911 call
Packed Red Blood Cells (PRBC) First 24 Hours
The average (mean) number of units of packed red blood cells (PRBC) transfused in the first 24 hours following the time of the 911 call in each group.
Measured: First 24 hours from the time dispatch received 911 call
Discharge Disposition
Disposition of patient at the time of discharge from the acute care hospital
Measured: Duration of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2009
- Study completionJan 2010
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,331 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), U.S. Army Medical Research and Development Command, Canadian Institutes of Health Research (CIHR), Canadian Department of National Defence, Heart and Stroke Foundation of Canada
- Investigators
- Myron L Weisfeldt, MD, Study chair, Resuscitation Outcomes Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316004
- Sponsor's protocol ID
- 28226-A - IND 12505
- Other IDs
- 5U01HL077863-05, IND #12505 TBI cohort
- Status last verified
- May 2011
- First submitted
- 17 Apr 2006
- Last updated
- 19 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bulger EM, May S, Brasel KJ, Schreiber M, Kerby JD, Tisherman SA, Newgard C, Slutsky A, Coimbra R, Emerson S, Minei JP, Bardarson B, Kudenchuk P, Baker A, Christenson J, Idris A, Davis D, Fabian TC, Aufderheide TP, Callaway C, Williams C, Banek J, Vaillancourt C, van Heest R, Sopko G, Hata JS, Hoyt DB; ROC Investigators. Out-of-hospital hypertonic resuscitation following severe traumatic brain injury: a randomized controlled trial. JAMA. 2010 Oct 6;304(13):1455-64. doi: 10.1001/jama.2010.1405.
PubMed 20924011Tisherman SA, Schmicker RH, Brasel KJ, Bulger EM, Kerby JD, Minei JP, Powell JL, Reiff DA, Rizoli SB, Schreiber MA. Detailed description of all deaths in both the shock and traumatic brain injury hypertonic saline trials of the Resuscitation Outcomes Consortium. Ann Surg. 2015 Mar;261(3):586-90. doi: 10.1097/SLA.0000000000000837.
PubMed 25072443
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)
- ClinicalTrials.gov ID
- NCT00316004
- Acronym / sponsor ID
- 28226-A - IND 12505
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Traumatic, Brain injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 1,331 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), U.S. Army Medical Research and Development Command, Canadian Institutes of Health Research (CIHR), Canadian Department of National Defence, Heart and Stroke Foundation of Canada
- Study start
- May 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 19 Apr 2006 (estimated)
- Results
- Posted 9 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if hypertonic saline with and without dextran can improve neurologic outcomes in victims of severe traumatic brain injury (TBI).
Injury and lost blood from trauma can cause your body to go into shock (low blood pressure related to blood loss). This decreased blood flow can lead to organ damage. In order to restore the blood pressure and blood flow, the medics give fluids into the patients' veins as soon as possible. This is called "resuscitation". The fluid most commonly used is "isotonic" or one that is the same salt concentration as the blood. The investigators are trying to determine if infusing a "hypertonic" fluid or one more concentrated than the blood can increase the blood pressure and restore blood flow more efficiently. The hypertonic fluids they are using are called hypertonic saline with dextran (HSD) and hypertonic saline (no dextran). Hypertonic saline is a salt solution that is slightly more concentrated than blood. Dextran is a sugar solution.
Detailed description
To determine if prehospital administration of 7.5% Hypertonic Saline in 6% Dextran-70 (HSD) OR 7.5% Hypertonic Saline (HS) compared to current standard therapy with NS as an initial resuscitation fluid affects neurological outcome following severe traumatic brain injury.
Trauma is the leading cause of death among North Americans between the ages of 1 and 44 years. The majority of these deaths result from hypovolemic shock or severe brain injury. Patients in hypovolemic shock develop a state of systemic tissue ischemia then a subsequent reperfusion injury at the time of fluid resuscitation. Conventional resuscitation involves the IV administration of a large volume of isotonic or slightly hypotonic (lactated ringers, LR) solutions beginning in the pre-hospital setting. Although not conclusive, prior studies have suggested that alternative resuscitation with hypertonic saline (7.5%) solutions may reduce morbidity or mortality in these patients. Furthermore, hypertonic fluids may have specific advantages in the brain-injured patient, as they may aid in the rapid restoration of cerebral perfusion and prevent extravascular fluid sequestration, thereby limiting secondary brain injury. In addition, recent studies have demonstrated that hypertonicity significantly alters the activation of inflammatory cells, an effect that may reduce subsequent organ injury from ischemia-reperfusion and decrease nosocomial infection.
This study is a randomized, double-blind, three-arm placebo controlled trial designed to evaluate the clinical outcome of trauma patients with severe TBI as manifested by a pre-hospital GCS of 8 or less. Patients will be randomized to a single 250cc IV dose of 7.5% saline in 6% Dextran-70 (HSD), 7.5% saline (HS) or normal saline as the initial fluid for pre-hospital resuscitation. No additional interventions will occur once the patient is admitted to the hospital. In hospital data collection will last up to 28 days. Patients will have neurologic outcome measurements at discharge, 1 month post discharge, and 6 months post injury. Enrollment will be restricted to age ≥ 15 years or ≥ 50 kg if age is unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 7.5% hypertonic saline/6% dextran (HSD) | Experimental | Drug: 7.5% Hypertonic Saline in 6% Dextran-70 (HSD)250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 |
| 7.5% hypertonic saline (HS) | Experimental | Drug: 7.5% Hypertonic Saline (HS)250 ml intravenous bolus administration of 7.5% hypertonic saline |
| 0.9% normal saline (NS) | Placebo comparator | Drug: 0.9% Normal Saline (NS)250 ml intravenous bolus administration of 0.9% saline |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Blunt trauma
- Pre-hospital Glasgow Coma Scale equal to or less than 8(GCS≤8)*
- Age 15 years or older or 50 kg or more
Key exclusion criteria (11 listed)
- Known or suspected pregnancy
- Age younger than 15 years or less than 50 kg if age unknown
- Ongoing pre-hospital cardiopulmonary resuscitation (CPR)
- Administration of more than 2L crystalloid or any colloid or blood products
- Severe hypothermia (T less than 28C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7.5% Hypertonic Saline in 6% Dextran-70 (HSD)Also: RescueFlo250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | Drug | 7.5% hypertonic saline/6% dextran (HSD) |
| 7.5% Hypertonic Saline (HS)250 ml intravenous bolus administration of 7.5% hypertonic saline administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | Drug | 7.5% hypertonic saline (HS) |
| 0.9% Normal Saline (NS)250 ml intravenous bolus administration of 0.9% saline administered as a one-time bolus fluid for initial resuscitation to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | Drug | 0.9% normal saline (NS) |
Primary outcome
Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Completer Analysis
Time frame: 6 months after injury
Glasgow outcome score extended (GOSE) contains eight categories: 1. Dead, 2. Vegetative State (VS), 3. Lower Severe Disability (Lower SD), 4. Upper Severe Disability (Upper SD), 5. Lower Moderate Disability (Lower MD), 6. Upper Moderate Disability (Upper MD), 7. Lower Good Recovery (Lower GR) and 8. Upper Good Recovery (Upper GR). A measured neurological outcome of GOSE≤4 is a poor outcome of severe disability, vegetative state, or death. Completer analysis includes only those patients with GOSE completed at 6 months after injury.
Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis
Time frame: 6 months after injury
Glasgow outcome score extended (GOSE) contains 8 categories: 1. Dead, 2. Vegetative State, 3. Lower Severe Disability, 4. Upper Severe Disability, 5. Lower Moderate Disability, 6. Upper Moderate Disability, 7. Lower Good Recovery and 8. Upper Good Recovery. To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group.
14 secondary outcomes
Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 4 (Head AIS≥4) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis
Time frame: 6 months after injury
Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 2 (Head AIS≥2) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis
Time frame: 6 months after injury
Disability Rating Score (DRS) Categories of Disability
Time frame: 6 months after injury
28 Day Survival
Time frame: 28 days after injury
Survival at Hospital Discharge up to 6 Months From Date of Injury
Time frame: Date of hospital discharge up to 6 months from date of injury
Acute Respiratory Distress Syndrome (ARDS)-Free Survival to Day 28
Time frame: From day of injury to 28 days after injury
Worst Multiple Organ Dysfunction Score (MODS) Through Day 28
Time frame: From day of injury to 28 days after injury
Ventilator-free Days Through Day 28
Time frame: From day of injury to 28 days after injury
Days Alive Out of the Intensive Care Unit (ICU) Through Day 28
Time frame: From day of injury to 28 days after injury
Days Alive Out of the Hospital Through Day 28
Time frame: From day of injury to 28 days after injury
Presence of Nosocomial Infections
Time frame: From day of injury to 28 days after injury
Total Fluids in First 24 Hours
Time frame: First 24 hours from the time dispatch received 911 call
Packed Red Blood Cells (PRBC) First 24 Hours
Time frame: First 24 hours from the time dispatch received 911 call
Discharge Disposition
Time frame: Duration of hospital stay
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20924011Bulger EM, May S, Brasel KJ, Schreiber M, Kerby JD, Tisherman SA, Newgard C, Slutsky A, Coimbra R, Emerson S, Minei JP, Bardarson B, Kudenchuk P, Baker A, Christenson J, Idris A, Davis D, Fabian TC, Aufderheide TP, Callaway C, Williams C, Banek J, Vaillancourt C, van Heest R, Sopko G, Hata JS, Hoyt DB; ROC Investigators. Out-of-hospital hypertonic resuscitation following severe traumatic brain injury: a randomized controlled trial. JAMA. 2010 Oct 6;304(13):1455-64. doi: 10.1001/jama.2010.1405.
- Derived from this study: PubMed 25072443Tisherman SA, Schmicker RH, Brasel KJ, Bulger EM, Kerby JD, Minei JP, Powell JL, Reiff DA, Rizoli SB, Schreiber MA. Detailed description of all deaths in both the shock and traumatic brain injury hypertonic saline trials of the Resuscitation Outcomes Consortium. Ann Surg. 2015 Mar;261(3):586-90. doi: 10.1097/SLA.0000000000000837.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myron L Weisfeldt, MD study chair
Resuscitation Outcomes Consortium
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 7.5% Hypertonic Saline in 6% Dextran-70 (HSD), 7.5% Hypertonic Saline (HS) and 0.9% Normal Saline (NS) in people with Brain Injuries, Traumatic, run by University of Washington at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Completer Analysis (time frame: 6 months after injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00316004, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.